EU rules on paediatric medicines come into force

A new law which came into effect on 26 January across the European Union that will give children better access to life-saving medicines has received a warm welcome, especially from groups working in the field of cancer.

The European Union Regulation on Paediatric Medicines aims to increase availability of treatments specifically adapted and licensed for use in the paediatric population which will involve making more information available to the patient/carer and prescriber, including clinical trial data, and encouraging more high-quality research into medicines for children. It also means that any new drug licensed in Europe must be explored for its potential use in children.

This is the first time specific legislation has been passed in the EU that regulates pharmaceutical research involving children – an area that has often been overlooked by drugmakers because of the small market, the challenges of undertaking trials in children and the high development costs. Now, companies that do conduct trials on new drugs will be offered incentives in the form of patent extensions of six months, rising to two years for 'orphan' drugs with a limited patient population. A new body, the Paediatric Committee, sited at the European Medicines Agency, will be set up to oversee testing.

The new law has been hailed by Cancer Research UK, which describes it as “a landmark ruling to help more children survive cancer.” Sally Burtles, director of the charity’s drug development office, said: “Childhood cancers are very different from adult tumours so specialist knowledge from groups such as the European consortium for Innovative Therapies for Children with Cancer and the Children’s Cancer and Leukaemia Group is crucial in order for advances to be made.”

She added that “this new law presents a massive boost to drug discovery programmes across Europe and will encourage further collaboration between pharmaceutical companies and childhood cancer experts.”